U.S. patent number 8,585,680 [Application Number 11/787,626] was granted by the patent office on 2013-11-19 for endovascular device tip assembly incorporating a marker device and method for making the same.
This patent grant is currently assigned to Cook Medical Technologies LLC. The grantee listed for this patent is Mark A. Magnuson, Jeffry S. Melsheimer. Invention is credited to Mark A. Magnuson, Jeffry S. Melsheimer.
United States Patent |
8,585,680 |
Magnuson , et al. |
November 19, 2013 |
**Please see images for:
( Certificate of Correction ) ** |
Endovascular device tip assembly incorporating a marker device and
method for making the same
Abstract
An endovascular device tip assembly and method of making the
same, incorporating a radiopaque marker usable with catheters and
other suitable endovascular devices is provided. The tip assembly
incorporates a radiopaque marker device by providing a counterbore
within a primary bore of a tubular tip of an endovascular device.
The marker device is fitted securely within the counterbore and the
tubular tip is further deformed distally of the marker in order to
secure the marker within the device.
Inventors: |
Magnuson; Mark A. (Bloomington,
IN), Melsheimer; Jeffry S. (Springville, IN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Magnuson; Mark A.
Melsheimer; Jeffry S. |
Bloomington
Springville |
IN
IN |
US
US |
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|
Assignee: |
Cook Medical Technologies LLC
(Bloomington, IN)
|
Family
ID: |
38822822 |
Appl.
No.: |
11/787,626 |
Filed: |
April 17, 2007 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20070287957 A1 |
Dec 13, 2007 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60792779 |
Apr 17, 2006 |
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Current U.S.
Class: |
604/529; 29/521;
29/557; 29/516 |
Current CPC
Class: |
A61M
25/0012 (20130101); A61M 25/0068 (20130101); A61M
25/0069 (20130101); A61M 25/001 (20130101); Y10T
29/49995 (20150115); Y10T 29/49927 (20150115); Y10T
29/49936 (20150115); A61M 25/0108 (20130101) |
Current International
Class: |
A61M
25/098 (20060101); B23P 11/00 (20060101); B21D
39/00 (20060101); B23P 13/04 (20060101) |
Field of
Search: |
;604/96.01,103.1,264,529
;29/516,521,557 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Mendez; Manuel
Assistant Examiner: Price; Nathan R
Attorney, Agent or Firm: Brinks Hofer Gilson & Lione
Claims
The invention claimed is:
1. A method of incorporating a marker into an endovascular device
tip comprising: providing a tubular tip of an endovascular device
comprising a distal end portion and at least one longitudinal bore
extending therethrough, said distal end portion comprising an
annular side wall and at least one outlet opening, wherein said
side wall includes an outer radial surface and an inner radial
surface defining a radial wall thickness, and said at least one
longitudinal bore is defined by an internal diameter; removing a
portion of material from the inner radial surface of the side wall
to create a counterbore within the side wall and through said
distal end portion, thereby increasing the internal diameter of
said at least one longitudinal bore and decreasing the thickness of
said side wall; providing a marker device; positioning said marker
device within said counterbore, said marker device having a first
end and a second end; and deforming a portion of said tubular tip
extending distally beyond said second end of said marker device to
retain said marker device within said counterbore.
2. The method of claim 1, wherein said internal diameter of said at
least one longitudinal bore is approximately equal to an internal
diameter of the marker device.
3. The method of claim 1, wherein said marker device is
cylindrically shaped.
4. The method of claim 3, wherein said marker device comprises
radiopaque material.
5. The method of claim 1, wherein said marker device is about 0.01
to about 0.125 inches in length.
6. The method of claim 1, wherein said internal diameter of said
counterbore is approximately from about 0.001 inches to about 0.125
inches larger than said internal diameter of said at least one
longitudinal bore.
7. The method of claim 6, wherein said internal diameter of said
counterbore is approximately 0.004 inches larger than said internal
diameter of said at least one longitudinal bore.
8. The method of claim 1, wherein said counterbore is further
defined by a first end and a second end defining a ledge between
said inner radial surface of said at least one longitudinal bore
and an inner surface of the counterbore; and wherein said first end
of the marker device is positioned adjacent said ledge.
9. The method of claim 8, wherein said ledge is approximately
0.0005 to about 0.0625 inches thick and said marker device has a
radial thickness approximately equal to said ledge.
10. The method of claim 9, wherein said ledge is approximately
0.002 inches thick and said marker device has a radial thickness
approximately equal to said ledge.
11. An endovascular tip device manufactured according to the method
of claim 1.
12. The method of claim 1, wherein the counterbore is formed by
drilling or grinding into the distal end portion of the tubular
tip.
13. The method of claim 1, wherein the tubular tip comprises a
catheter body and the counterbore is formed by a molding process of
the catheter body.
14. The method of claim 1, wherein the marker device is positioned
within the inner radial surface of the tubular tip so that the
outer diameter of the distal end portion surrounding the marker
device remains substantially unchanged following said positioning
of the marker device.
15. An endovascular device, comprising: a tubular tip of said
endovascular device comprising a distal end portion and a proximal
end portion, said distal end portion having a first portion and a
second portion, said first portion of said distal end portion
having an internal diameter larger than an internal diameter of
said proximal end portion; a radiopaque marker having a first end
and a second end and being disposed within said first portion of
the distal end portion, said second portion of the distal end
portion being deformed distally of the second end of the radiopaque
marker; and, wherein each of said proximal and distal end portions
comprises an annular side wall, the proximal annular side wall
having a first radial wall thickness, the distal annular side wall
having a second radial wall thickness less than the first radial
wall thickness, wherein both the first and second portions of the
distal end portion comprise the second radial wall thickness.
16. The endovascular device of claim 15, wherein said second
portion of the distal end portion extending beyond said second end
of said marker is approximately 0.05 cm to about 2.0 cm.
17. The endovascular device of claim 15, wherein said second
portion of the distal end portion extending beyond said second end
of said marker device is deformed by heat tapering said second
portion and gradually decreasing said internal diameter of said
second portion, securely affixing said marker device to said
tubular tip.
18. The endovascular device of claim 15, wherein said tubular tip
is formed integrally on a distal end of a catheter body.
19. The endovascular device of claim 15, wherein said tubular tip
is bonded on a distal end of a catheter body.
20. The endovascular device of claim 15, wherein the distal annular
side wall portion is tapered to create an outlet opening having a
reduced outer diameter relative to the outer diameter of the
proximal end portion.
Description
BACKGROUND
This application claims priority to U.S. Provisional Application
60/792,779, filed on Apr. 17, 2006.
The present application relates to an endovascular device tip
assembly incorporating a marker and the method of making the same.
Moreover, this application relates to the use of a radiopaque
marker that is fixed within a medical device, such as a catheter,
by counterboring the distal end of a tubular device and placing the
marker within.
Endovascular devices have long been known which can be surgically
inserted into a body lumen, such as an artery, to reinforce,
support, repair, or otherwise enhance the performance of the lumen.
For example, catheters generally include a hollow tubular portion,
usually formed of resilient plastic, for insertion through the skin
of a patient into a cavity, duct or vessel to permit injection or
withdrawal of fluids, or to deliver medications to patients for
therapeutic reasons. Regardless of the instrument, the accurate
placement of the instrument in the patient's body is often critical
to its successful use.
As a result, different methods have been developed to help the
physician "see" inside of the patient's body and help determine
exactly where the endovascular device is being positioned. For
example, X-ray, MRI, CT, and ultrasound devices and techniques have
been employed. The endovascular devices may still be difficult to
position without some enhancement of the device. Medical devices
which incorporate radiopaque materials may more accurately position
the various medical implements.
Typically, the distal tip of an endovascular device consists of a
hollow metal or polymer cylinder which is tapered along the outer
surface. The inside diameter of the tip is typically sized to allow
the smooth passage of a guidewire of a given diameter. Preferably,
the inside diameter remains constant. Therefore, it is desirable to
develop a method of incorporating a marker into the tip of an
endovascular device without changing the inner diameter of the tip,
which would make it more difficult to pass a guidewire
therethrough. This invention addresses such a method for
incorporating a marker into the tip of an endovascular device.
BRIEF SUMMARY
The endovascular tip device described below may overcome the
aforementioned problems and relates to a medical device, and more
particularly, to an endovascular tip device assembly and method of
making the same that incorporates a radiopaque marker device within
the tip assembly.
A method of incorporating a marker into an endovascular device tip
is disclosed. This method comprises providing a tubular tip of an
endovascular device comprising a distal end portion and at least
one longitudinal bore extending therethrough, the distal end
portion comprising at least one outlet opening and the at least one
longitudinal bore having an internal diameter; creating a
counterbore through the distal end portion of the tubular tip,
thereby increasing the internal diameter of the at least one
longitudinal bore; providing a marker device; positioning the
marker device within the counterbore, the marker device having a
first end and a second end; and deforming a portion of the tubular
tip extending distally beyond the second end of the marker device
to retain the marker device within the counterbore.
The method described above wherein the internal diameter of the at
least one longitudinal bore is approximately equal to an internal
diameter of the marker device.
The method described above wherein the marker device is
cylindrically shaped.
The method described above wherein the cylindrical marker device
comprises radiopaque material.
The method described above wherein the marker device is about 0.01
to about 0.125 inches in length.
The method as described above, wherein the internal diameter of the
counterbore is approximately from about 0.001 inches to about 0.125
inches larger than the internal diameter of the at least one
longitudinal bore.
The method described above wherein the internal diameter of the
counterbore is approximately 0.004 inches larger than the internal
diameter of the at least one longitudinal bore.
The method described above wherein the at least one longitudinal
bore is further defined by an outer radial surface and an inner
radial surface; and wherein the counterbore is further defined by a
first end and a second end defining a ledge between the inner
surface of the at least one longitudinal bore and an inner radial
surface of the counterbore; and wherein the first end of the marker
device is adjacent the ledge.
The method described above, wherein the ledge is approximately
0.0005 to about 0.0625 inches thick and the marker device has a
thickness approximately equal to the ledge.
The method described above wherein the ledge is approximately 0.002
inches thick and wherein the marker device has a thickness
approximately equal to the ledge.
An endovascular tip device manufactured according to the method as
described above.
An endovascular device is disclosed comprising: a tubular tip of
the endovascular device having a distal end portion and a proximal
end portion, the distal end portion having an internal diameter
larger than an internal diameter of the proximal end portion; a
radiopaque marker having a first end and a second end and being
disposed within the distal end portion; and the distal end portion
having a length deformed distally of the second end portion of the
radiopaque marker.
The endovascular device described above wherein the length
extending beyond the second end of the marker is approximately 0.05
cm to about 2.0 cm.
The endovascular device described above wherein the length
extending beyond the second end of the marker device is deformed by
heat tapering the length and gradually decreasing the internal
diameter of the distal end, securely affixing the marker tubular
tip.
The endovascular device described above wherein the tubular tip is
formed integrally on a distal end of a catheter body.
The endovascular device described above wherein the tubular tip is
bonded on a distal end of a catheter body.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is side view of the tip of an endovascular device and the
marker device in a final configuration of the present
invention;
FIG. 2 is side view an endovascular device prior to incorporation
of the counterbore;
FIG. 3 is side view an endovascular device prior to incorporation
of the marker device; and
FIG. 4 is side view of the tip of an endovascular device and the
marker device in an untapered configuration.
DETAILED DESCRIPTION
An exemplary embodiment of the present invention may be described
in use with any endovascular device, but for the purposes of this
application, will be referred to as a catheter. To be clear, the
tip assembly will be described in accordance with the following
method, but other equivalent methods are contemplated by the
invention.
Referring now to FIG. 1, the method of the present invention for
incorporating a marker within a tip of an endovascular device, for
example a catheter, includes providing a tubular tip 10 of any
desired length having a primary bore 12 for directing fluids or
mechanical devices, such as stents, to and from the body of the
patient. The tubular tip 10 may be integral with the catheter body
of a single lumen catheter system, such as a balloon catheter. On
catheter based systems that include multiple lumens, the tip may be
integral with the innermost lumen. Alternatively, the tubular tip
may be glued or heat molded to the outermost catheter body. This
technique may result in a larger overall profile of the distal end
of the catheter-based system.
As shown in FIG. 2, the tubular tip 10 of a catheter body includes
a distal end portion 14 and a proximal end portion 16. The distal
end portion 14 may define an outlet opening 18 of the primary bore
12. The tubular tip 10 also may include an annular side wall 20
having an outer radial surface 22 and an inner radial surface 24
further defining the bore 12 of the tip 10. The tubular tip 10 of
the catheter body may be formed of any appropriate material which
may be inserted into the human body, but is preferably formed of a
flexible material such as nickel-titanium alloys, polyethylene,
nylon, PVC, polyurethane or silicone. The tubular tip 10 may also
include various support structures, such as woven or helical
reinforcements. The reinforcements may be in the form of wires or
bands.
The inner radial surface 24 of the side wall 20 may include a first
inner diameter D1. The first inner diameter D1 may generally be
between about 0.010 inches to about 0.25 inches, and may desirably
be about 0.017 inches wide. Generally, the side wall 20 of the
catheter body may be about 0.004 inches thick, measured from the
outer radial surface 22 to the inner radial surface 24 of the bore
12. Alternatively, the side wall 20 may range from about 0.001 to
about 0.125 inches thick.
Referring now to FIG. 3, the method further includes forming a
counterbore 26 within the tip 10. The counterbore 26 is generally
created within the distal end portion 14 of the tubular tip 10. The
counterbore 26 may be created in an unmodified tube in a variety of
ways. Preferably, but not limited to, the inner radial surface 34
of the bore 12 may be prepared by drilling or grinding the
counterbore 26 into the distal end portion 14 of the tubular tip
10. The counterbore 26 may also be formed during the molding
process of the catheter body or may be cut or reformed into the tip
after the catheter is formed.
Starting at or about the outlet opening 18 of the tip 10, the
counterbore 26 may be formed within the annular side wall 20 of the
catheter body, lengthwise, toward the proximal end portion 16 of
the tubular tip 10. The counterbore 26 provides an enlarged inner
diameter, or a secondary inner diameter D2, within a portion of the
bore 12. The counterbore 26 may decrease the thickness of the side
wall 20 by approximately half of the original wall thickness. One
embodiment of the present invention includes a wall thickness of
about 0.004 inches. The resulting secondary inner diameter D2 may
be about 0.014 to about 0.254 inches, depending on the original
thickness of the initial inner diameter of the tip 10. For example,
if D1 is originally 0.017 inches, the resulting inner diameter of
the bore D2 would be approximately 0.021 inches.
The proximal end 28 of the counterbore 26 generally forms a ledge
30 within the tubular tip 10 of the catheter body. This ledge 30 is
generally the same thickness of the marker 32 that is to be
incorporated into the tip 10. Such a marker 32 may generally be
about 0.002 inches thick. The thickness of the marker and the ledge
generally correspond to the size of the counterbore.
Referring now to FIG. 4, the method further includes providing a
cylindrical band, marker 32, formed of a radiopaque, or other
suitable, material having an outer diameter D3 which generally
corresponds to the secondary inner diameter D2 of the tubular tip
10 as defined by the inner radial surface 34 of the counterbore 26,
and an inner diameter DA4, generally corresponding to D1. The
marker 32 may be formed of an x-ray reflective, or radiopaque,
material which may be viewed by the physician via radiography,
fluoroscopy, or other usual visualization techniques. The marker
may be a cylindrical metal sleeve, formed of palladium, iridium,
gold, tantalum, tungsten, platinum, or other suitable radiopaque
material. It is also contemplated that the marker may be a
radiopaque polymer, such as radiopaque nylon. Bismuth, barium, and
tungsten are examples of suitable fillers that may be used to make
polymers radiopaque.
Preferably, the marker is a cylindrical sleeve, but it also may be
a split cylinder, a half moon shape, a radiopaque ring, or other
suitable shape that would allow the marker to be friction fit or
otherwise secured within the counterbore of the tubular tip.
The marker 32 is incorporated into the catheter body within the
distal end portion 14 of the tip 10 so as to accurately mark the
position of the distal end of the catheter when exposed to x-rays.
The marker 32 may be a cylindrical band having an outer radial
surface 42 and an inner radial surface 40 defining a center bore
which terminates at a first end 36 and at a second, opposite end
38. The first end 36 of the marker 32 may be manually positioned
adjacent the ledge 30 of the counterbore 26 so that the inner
radial surface 40 of the cylindrical marker 32 extends no further
radially inward than the inner radial surface 24 of the bore 12 of
the tubular tip 10 of the catheter body. As a result, the inner
radial surface 24 of the bore 12 is substantially constant without
interruptions or inwardly extending ridges formed by the first 36
and second ends 38 of the cylindrical marker 32. The marker may
also be placed within the counterbore by use of an automated
machine, and it may be molded in to the counterbore upon formation
of the tip.
Because the inner radial surface 24 of the tip 10 remains
substantially constant, it prevents the formation of internal
restrictions in the primary bore 12 thereby maintaining a constant
inner diameter D1 and D4.
Also, because the marker 32 is positioned within the inner radial
surface 24 of the tip 10, the outer radial surface 22 may remain
smooth. A smooth outer radial surface 22 is advantageous on many
medical instruments that are to be inserted into a patient's body
since the outer surface slides against the patient's skin and
internal tissue. A smooth outer surface 22 allows the medical
instrument to more easily be pushed through a patient's skin or
other openings with small clearances while minimizing harm to the
patient.
Referring again to FIG. 1, in order to securely incorporate the
marker 32 of the present invention into the catheter body, the
method of the present invention further includes deforming or
tapering the distal end portion 14 of the tip 10 that extends
beyond the second end 38 of the marker 32. One way to taper the tip
10 is by heating and/or applying pressure to the distal end portion
14. The tip 10 may be reformed to a desired diameter, generally
accommodating the diameter of the wire guide to be used with the
device. The wall of the tip 10 may also be formed around the marker
32 so that a portion of the wall abuts the second end 38 of the
marker 32, further securing the marker 32 within the device.
In use, the tubular tip 10 of the endovascular device is inserted
into a patient's body to perform one or more of a variety of
functions including the delivery and withdrawal of fluids and
mechanical devices such as stents. As is apparent, the present
invention may be used to incorporate radiopaque markers 32 formed
of various suitable materials in to many different types of
endovascular devices including delivery catheters, angioplasty
balloons and other endoscopic instrumentation.
When the device is positioned in the patient's body and the body is
exposed to x-rays, the radiopaque marker 32 provides a clear
indication to the physician as to the precise location of the
marked portion of the instrument. The marker 32 may also be
provided with indicia marked or etched into the outer surface of
the band. These indicia may be visible when exposed to x-rays
during use so as to assist the physician in the procedure by, for
example, distinguishing the catheter from an adjacent catheter.
It is therefore intended that the foregoing detailed description be
regarded as illustrative rather than limiting, and that it be
understood that it is the following claims, including all
equivalents, that are intended to define the spirit and scope of
this invention.
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